Talaris Therapeutics, Inc. presented additional data and analyses from its Phase 2 trial of FCR001 and other studies of its Facilitated Allo-HSCT Therapy platform at the 2022 American Transplant Congress (ATC). A conference call to provide an interim update on the FREEDOM-1 study, originally planned for June 8, 2022, has been rescheduled pending receipt of data from all participating sites and will now be held on June 30, 2022. Real-world data comparison of matched controls to Phase 2 treated patients. In a poster presented at the 2022 ATC meeting, Talaris reported findings of a retrospective, real-world assessment of the safety and efficacy of FCR001 as compared with standard of care (SOC) immunosuppression. Medical records were used to identify 144 patients who received transplants contemporaneously and at the same institution as 36 of the 37 Phase 2 clinical trial participants, and who met the study's inclusion and exclusion criteria, including age, HLA mismatch and BMI. The analysis indicated that patients treated with FCR001 had no higher incidence of death, graft loss or biopsy-proven acute rejection than did patients on IS in the five years post-transplant. Kidney function, defined as estimated glomerular filtration rate (eGFR), was significantly higher in patients treated with FCR001 at five years (p=0.02), and key immunosuppression-related cardiometabolic complications were observed less frequently in patients treated with FCR001 compared to those on IS. Phase 2 long-term follow-up shows consistent durability off IS. In an oral presentation at the 2022 ATC meeting, Talaris provided an update on the continued long-term follow-up of patients in its Phase 2 LDKT study. Talaris previously reported that 26 of 37 (70%) patients in its Phase 2 study achieved stable T-cell chimerism and were weaned off all chronic IS by approximately 12 months after their transplant. To date, all surviving patients weaned off IS remain IS- and rejection-free. Talaris has followed these patients from five to 12.8 years post-transplant. Six subjects have remained off IS > 10 years. In the Phase 2 study, Talaris did not observe any correlation between the degree of HLA mismatch and the safety or efficacy measures in the study. Patients at all levels of HLA matching were able to discontinue chronic immunosuppression, with 19 out of 26 recipients (73%) who durably discontinued their chronic IS having an HLA match of three or less to their donor.
As of May 31, 2022, Talaris has accumulated over 250 patient-years of exposure to FCR001 in LDKT, and the safety profile observed in the Phase 2 patients remains generally consistent with that expected with kidney and allogeneic stem cell transplantation involving non-myeloablative conditioning.